RecruitingRecruiting
A Study of Olverembatinib in Patients With Newly Diagnosed Ph+ ALL (POLARIS-1)
NCT06051409 · Ascentage Pharma Group Inc.
In plain English
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Official title
A Pivotal Registrational Phase 3 Study of Olverembatinib Combined With Chemotherapy Versus Investigator's Choice of TKI Combined With Chemotherapy in Patients With Newly Diagnosed Ph+ ALL
About this study
Comparing efficacy and safety of olverembatinib in combination with chemotherapy (investigational arm) vs. investigator's choice of TKI in combination with chemotherapy (control arm).
Eligibility criteria
Inclusion Criteria:
1. Newly diagnosed Philadelphia chromosome-positive (Ph+) Acute Lymphoblastic Leukemia (ALL)
2. Expected survival of at least 3 months
3. ECOG ≤ 2
4. Adequate organ function
Exclusion Criteria:
1. A history of chronic myeloid leukemia (CML)
2. Clinical manifestations of central nervous system (CNS) leukemia or ALL extramedullary infiltration, except lymphadenopathy or hepatosplenomegaly
3. Previous or current clinical CNS diseases
4. Autoimmune diseases that may involve the CNS
5. Use of therapeutic doses of anticoagulants and/or antiplatelet agents; low doses of anticoagulants or antiplatelet agents are allowed
6. Use a therapeutic drug that has drug interaction with the investigational drug due to other diseases within 7 days or within 5 half-lives (whichever is shorter) prior to the first receipt of the investigational drug
7. Uncontrolled heart diseases
8. Any venous thromboembolism in the 6 months prior to randomization, including but not limited to deep vein thrombosis (DVT) or pulmonary embolism
9. Use of prohibited drugs
10. Disease or medical condition that is unstable or may affect its safety or compliance with the study
11. Use of medications known to cause prolonged QT interval
12. Active infections requiring systemic treatment
13. Disease that severely affects the oral administration and absorption of drugs, or an active gastrointestinal ulcer
14. Contraindications to the use of glucocorticoids
15. Bleeding disorders unrelated to ALL
16. Plan to undergo major surgery
17. Allergy to drug ingredients, excipients, or their analogues in the study
18. Female subjects who are pregnant or breastfeeding or expect to become pregnant during the study period
19. Other malignant tumors within 2 years
20. Any symptom or illness that may interfere with the evaluation of the efficacy and safety of the investigational drug, or any other condition or condition that is not appropriate for participation in the study
Study design
Enrollment target: 350 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2023-08-31
Estimated completion: 2029-06-30
Last updated: 2026-04-30
Interventions
Drug: OlverembatinibDrug: Investigator's choice of TKI
Primary outcomes
- • Minimal Residual Disease Negative CR Rate (Cycle 1 to Cycle 3 (each cycle is 28 days))
Sponsor
Ascentage Pharma Group Inc. · industry
With: Guangzhou Healthquest Pharma Co., Ltd
Contacts & investigators
ContactAscentage Clinical Operations · contact · clinical-trials@ascentage.com · 301-291-5658
InvestigatorElias Jabbour, M.D. · principal_investigator, M.D. Anderson Cancer Center
InvestigatorWeili Zhao, M.D., Ph.D. · principal_investigator, Shanghai Jiaotong University School of Medicine Ruijin Hospital
InvestigatorSuning Chen, M.D., Ph.D. · principal_investigator, First Affiliated Hospital of Suzhou Medical College
All locations (90)
Ascentage Investigative Site #1044Not Yet Recruiting
Birmingham, Alabama, United States
Ascentage Investigative Site #1062Not Yet Recruiting
Duarte, California, United States
Ascentage Investigative Site #1134Not Yet Recruiting
Los Angeles, California, United States
Ascentage Investigative Site #1059Not Yet Recruiting
Los Angeles, California, United States
Ascentage Investigative Site #1142Not Yet Recruiting
Miami, Florida, United States
Ascentage Investigative Site #1045Not Yet Recruiting
Augusta, Georgia, United States
Ascentage Investigative Site #1158Not Yet Recruiting
Indianapolis, Indiana, United States
Ascentage Investigative Site #1069Not Yet Recruiting
Indianapolis, Indiana, United States
Ascentage Investigative Site #1084Not Yet Recruiting
Lexington, Kentucky, United States
Ascentage Investigative Site #1064Not Yet Recruiting
Hackensack, New Jersey, United States
Ascentage Investigative Site #1098Not Yet Recruiting
New Brunswick, New Jersey, United States
Ascentage Investigative Site #1160Not Yet Recruiting
Stony Brook, New York, United States
Ascentage Investigative Site #1151Not Yet Recruiting
The Bronx, New York, United States
Ascentage Investigative Site #1501Not Yet Recruiting
Houston, Texas, United States
Ascentage Investigative Site #1806Not Yet Recruiting
Seattle, Washington, United States
Ascentage Investigative Site #1155Not Yet Recruiting
Morgantown, West Virginia, United States
Royal North Shore HospitalActive Not Recruiting
St Leonards, New South Wales, Australia
Royal Adelaide HospitalActive Not Recruiting
Adelaide, South Australia, Australia
Alfred HealthActive Not Recruiting
Melbourne, Victoria, Australia
Royal Perth HospitalActive Not Recruiting
Perth, Washington, Australia
The First Affiliated Hospital of Bengbu Medical SchoolNot Yet Recruiting
Bengbu, Anhui, China
Xinqiao Hospital of Army Medical UniversityRecruiting
Chongqing, Chongqing Municipality, China
Guangdong Province People's HospitalRecruiting
Guangdong, Guangzhou, China
Nanfang Hospital of Southern Medical UniversityRecruiting
Guangdong, Guangzhou, China
Henan Cancer HospitalRecruiting
Zhengzhou, Henan, China
Wuhan Union Hospital of Tongji Medical College of Huazhong University of Science and TechnologyRecruiting
Wuhan, Hubei, China
The First Affiliated Hospital of Suzhou UniversityRecruiting
Suzhou, Jiangsu, China
Shanghai Jiao Tong University School of Medicine Ruijin HospitalNot Yet Recruiting
Shanghai, Shanghai Municipality, China
West China Hospital of Sichuan UniversityRecruiting
Chengdu, Sichuan, China
Institute of Blood Transfusion of Chinese Academy of Medical SciencesRecruiting
Tianjin, Tianjin Municipality, China
Ascentage Investigative Site #8647Not Yet Recruiting
Brno, Czechia
Ascentage Investigative Site #6305Not Yet Recruiting
Hradec Králové, Czechia
Ascentage Investigative Site #6304Not Yet Recruiting
Ostrava, Czechia
Ascentage Investigative Site #6302Not Yet Recruiting
Prague, Czechia
Ascentage Investigative Site #6309Not Yet Recruiting
Prague, Czechia
Ascentage Investigative Site #5020Not Yet Recruiting
Le Chesnay, France
Ascentage Investigative Site #5021Not Yet Recruiting
Lyon, France
Ascentage Investigative Site #5013Not Yet Recruiting
Nantes, France
Ascentage Investigative Site #5025Not Yet Recruiting
Nice, France
Ascentage Investigative Site #5019Not Yet Recruiting
Pessac, France
Ascentage Investigative Site #5024Not Yet Recruiting
Pierre-Bénite, France
Ascentage Investigative Site #5022Not Yet Recruiting
Poitiers, France
Ascentage Investigative Site #5018Not Yet Recruiting
Toulouse, France
Ascentage Investigative Site #5538Not Yet Recruiting
Bologna, Italy
Ascentage Investigative Site #5529Not Yet Recruiting
Meldola, Italy
Ascentage Investigative Site #5539Not Yet Recruiting
Milan, Italy
Ascentage Investigative Site #5533Not Yet Recruiting
Monza, Italy
Ascentage Investigative Site #5540Not Yet Recruiting
Ravenna, Italy
Ascentage Investigative Site #5531Not Yet Recruiting
Roma, Italy
Ascentage Investigative Site #5550Not Yet Recruiting
Torino, Italy
Ascentage Investigative Site #5536Not Yet Recruiting
Varese, Italy
Ascentage Investigative Site #6503Not Yet Recruiting
Bucharest, Romania
Ascentage Investigative Site #6502Not Yet Recruiting
Cluj-Napoca, Romania
Ascentage Investigative Site #6507Not Yet Recruiting
Craiova, Romania
Ascentage Investigative Site #6504Not Yet Recruiting
Iași, Romania
Ascentage Investigative Site #6602Not Yet Recruiting
Singapore, Singapore
Ascentage Investigative Site #6603Not Yet Recruiting
Singapore, Singapore
Ascentage Investigative Site #6604Not Yet Recruiting
Singapore, Singapore
Ascentage Investigative Site #8206Not Yet Recruiting
Busan, South Korea
Ascentage Investigative Site #8207Not Yet Recruiting
Busan, South Korea
Ascentage Investigative Site #8201Not Yet Recruiting
Seoul, South Korea
Ascentage Investigative Site #8202Not Yet Recruiting
Seoul, South Korea
Ascentage Investigative Site #8203Not Yet Recruiting
Seoul, South Korea
Ascentage Investigative Site #8208Not Yet Recruiting
Uijeongbu-si, South Korea
Ascentage Investigative Site #6018Not Yet Recruiting
Badalona, Spain
Ascentage Investigative Site #6019Not Yet Recruiting
Badalona, Spain
Ascentage Investigative Site #6020Not Yet Recruiting
Barcelona, Spain
Ascentage Investigative Site #6048Not Yet Recruiting
Cáceres, Spain
Ascentage Investigative Site #6016Not Yet Recruiting
Madrid, Spain
Ascentage Investigative Site #6049Not Yet Recruiting
Madrid, Spain
Ascentage Investigative Site #6035Not Yet Recruiting
Madrid, Spain
Ascentage Investigative Site #6013Not Yet Recruiting
Madrid, Spain
Ascentage Investigative Site #6011Not Yet Recruiting
Madrid, Spain
Ascentage Investigative Site #6021Not Yet Recruiting
Santander, Spain
Ascentage Investigative Site #6050Not Yet Recruiting
Seville, Spain
Ascentage Investigative Site #6017Not Yet Recruiting
Valencia, Spain
Ascentage Investigative Site #9201Not Yet Recruiting
Ankara, Turkey (Türkiye)
Ascentage Investigative Site #9204Not Yet Recruiting
Ankara, Turkey (Türkiye)
Ascentage Investigative Site #9212Not Yet Recruiting
Ankara, Turkey (Türkiye)
Ascentage Investigative Site #9209Not Yet Recruiting
Ankara, Turkey (Türkiye)
Ascentage Investigative Site #9205Not Yet Recruiting
Antalya, Turkey (Türkiye)
Ascentage Investigative Site #9203Not Yet Recruiting
Istanbul, Turkey (Türkiye)
Ascentage Investigative Site #9202Not Yet Recruiting
Izmir, Turkey (Türkiye)
Ascentage Investigative Site #9211Not Yet Recruiting
Kayseri, Turkey (Türkiye)
Ascentage Investigative Site #9208Not Yet Recruiting
Mersin, Turkey (Türkiye)
Ascentage Investigative Site #9220Not Yet Recruiting
Samsun, Turkey (Türkiye)
Ascentage Investigative Site #9210Not Yet Recruiting
Tekirdağ, Turkey (Türkiye)
Ascentage Investigative Site #7002Not Yet Recruiting
Birmingham, United Kingdom
Ascentage Investigative Site #7034Not Yet Recruiting
Glasgow, United Kingdom
Ascentage Investigative Site #7019Not Yet Recruiting
London, United Kingdom